iTotal Identity PS TPS-101-1112

GUDID M572TPS1011112111

ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED), RIGHT or left

Conformis, Inc.

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic
Primary Device IDM572TPS1011112111
NIH Device Record Key3681cce9-79f2-457d-a95d-6f58ddef59c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal Identity PS
Version Model NumberTPS-101-111211
Catalog NumberTPS-101-1112
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572TPS1011112111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-25
Device Publish Date2022-08-17

Devices Manufactured by Conformis, Inc.

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M572POV0123208011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly
M572POV0123509011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly
M572POV0123809011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly
M572POV0124110011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 41MM X 10MM, iPoly
M572POV0124411011 - Identity Imprint Porous CR 2023-09-18 POROUS OVAL PATELLA, 44MM X 11MM, iPoly
M572TCR102F01S011 - Identity Imprint Porous CR2023-09-18 POROUS CR FEMORAL IMPLANT SIZE 1 LEFT OR RIGHT
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